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Advanced Tissue Sciences

This article was originally published in The Gray Sheet

Executive Summary

Firm is enrolling patients in IDE-approved Dermagraft diabetic foot ulcer clinical trial in compliance with recommendation of FDA's General and Plastic Surgery Devices Panel, which voted to approve the company's PMA application on the condition that additional studies be completed ("The Gray Sheet" Feb. 2, p. 6). If initial trials including180 patients at up to 30 sites show that healing rates are equivalent to earlier pivotal trials, the firm can terminate the study and will have sufficient data to support its PMA application within a year. The trial will continue until 330 patient have been enrolled if such results are not obtained. Separately, Dermagraft-TC will be sold as TransCyte effective Oct. 1
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